Trading Away Health
How the U.S.’s Intellectual Property Demands for the Trans-Pacific Partnership
Agreement Threaten Access to Medicines
Encompassing eleven countries and slated for further expansion across the Asia Pacific region, the
Trans-Pacific Partnership Agreement (TPP) is a regional trade agreement that will “set the standard for
21st-century trade agreements going forward.” 1
The TPP negotiations are being conducted in secret, but leaked drafts2 of the U.S. negotiating positions
show that the U.S. is demanding aggressive intellectual property (IP) provisions that would roll back
public health safeguards enshrined in international trade law in favor of offering enhanced patent and
data protections to pharmaceutical companies, making it harder to gain access to affordable generic
drugs and hindering needed innovation.
If the U.S.’s demands are accepted, the TPP agreement will impose new IP rules that could severely
restrict access to affordable, life-saving medicines for millions of people. Billed by President Obama
as “a model not just for countries in the Pacific region, but for the world generally,”3 the TPP will set a
damaging precedent with serious implications for developing countries where MSF works, and
beyond.

Closed-Door Negotiations with Far-Reaching Impacts
MSF opposes the secrecy under which the TPP
negotiations are being conducted, which forces MSF,
civil society and other interested stakeholders to rely on
“leaked texts” to evaluate the impact of an agreement
that will affect more than half a billion people in at least
11 countries, and potentially many more. The closeddoor nature of the TPP negotiations has also come
under intense criticism from some members of the U.S.
Congress (see Appendix B), as well as public health
advocates and consumer groups,4 who have asked the
U.S. Administration to increase transparency and allow
public scrutiny by making negotiating positions and texts
public. As it stands, only the final agreed-upon text will
be made publicly available – after it is too late to
evaluate the public health impact or modify egregious
provisions.

The norms that emerge from these negotiations are expected to serve as a baseline for future trade
agreements, potentially impacting a much wider group of countries. Yet unlike in negotiations under the
auspices of the World Health Organization (WHO), World Trade Organization (WTO) or World
Intellectual Property Organization (WIPO), the TPP process does not allow public scrutiny of the specific
provisions being negotiated. Meanwhile, more than 600 corporate representatives on government
advisory boards do have full access to the U.S. negotiating positions.5
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MSF Access Campaign
TPP Issue Brief – August 2012

Most Egregious U.S. Demands Affecting Access to Medicines
According to leaked drafts of the negotiating texts, the U.S. is demanding aggressive intellectual
property provisions—so-called “TRIPS-plus” provisions—that, if accepted, would directly undermine
public health safeguards available in international law, making it harder for TPP countries to gain access
to price-lowering generic competition.
Some of the specific TRIPS-plus IP provisions that the U.S. is demanding:

Make it impossible to challenge the validity of a patent before it is granted

Lower the requirements for patentability, so that minor alterations of existing medicines can be
given additional protected monopoly status, even if the alteration offers no therapeutic benefit

Require the patenting of diagnostic, therapeutic and surgical methods

Lengthen patent monopolies for pharmaceutical firms so that they keep generics out and prop up
drug prices for longer periods of time

Make it harder for generic manufacturers to obtain regulatory approval for their drugs

Create additional monopolies based on clinical data

Impose new forms of IP enforcement that give customs officials excessive powers to impound
legitimate generic medicines

Impose higher prices on national pharmaceutical reimbursement programs

Allow pharmaceutical companies to sue governments and limit governments’ abilities to
effectively set prices for medicines and legislate in the interest of public health
By insisting on the inclusion of these provisions, the U.S. is turning its back on existing commitments to
preserve public health safeguards in trade agreements with developing countries, including a bipartisan
congressional agreement and numerous multilateral agreements under the auspices of the United
Nations, World Trade Organization (WTO) and World Health Organization (WHO).
Furthermore, the U.S.’s hardline IP demands threaten the sustainability of the very global health
programs it supports, including U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global
Fund to Fight AIDS, Tuberculosis and Malaria, which rely heavily on availability and affordability of
generic medicines.

MSF Recommendations






3

Withdraw TRIPS-plus requests: The U.S. should not seek to impose TRIPS-plus provisions (i.e.,
broader scope of patentability, limits on patent oppositions, new forms of enforcement, data
exclusivity, patent extensions, and patent linkage) on TPP countries. At a minimum, the U.S.
government should not walk away from bipartisan public health protections established in the May
10, 2007 New Trade Policy agreement.
Increase transparency: The TPP is being negotiated in secret. Trade agreement negotiations that
affect public health must be conducted with adequate levels of transparency and public scrutiny,
both with respect to the actual negotiating texts under discussion and the relevant negotiating
positions and demands of each country.
Recognize previous commitments to access to medicines and innovation: The U.S. should ensure
that the final text of the TPP agreement is aligned with U.S. global health priorities and specifically
mentions and honors the commitments made in the 2001 WTO Doha Declaration on TRIPS and
Public Health, the 2008 WHO Global Strategy and Plan of Action on Public Health, Innovation, and
Intellectual Property, and the U.S.’s own May 10, 2007 New Trade Policy, a bipartisan agreement to
include important global public health safeguards in trade agreements with developing countries.
MSF Access Campaign
TPP Issue Brief – August 2012

Generic Competition as a Catalyst for Access to Medicines
In the field of health, generic competition saves lives. Monopolies enforced by patents and other
intellectual property regimes keep the price of medicines out of the reach for many patients, especially
in the developing world.
The price of HIV treatment has fallen by roughly 99 percent over the last ten yearsâ&#x20AC;&#x201D;from over
US$10,000 for one year's treatment in 2000, to less than $150 per person per year today, thanks to
generic production in India, Brazil, and Thailand, where these drugs were not patented. This dramatic
price drop has been instrumental in helping scale up HIV/AIDS treatment for more than eight million6
people in developing countries.

Generic Competition Drops HIV Drug Pricing by 99 Percent

The price for first-line ARVs fell by 99% over ten years.
Source: MSF Untangling the Web of Antiretroviral Price Reductions, 15th Edition, July 2012

All the major international treatment
initiatives for developing countries,
including the Global Fund, PEPFAR,
UNITAID, and UNICEF, rely on affordable,
quality generic drugs as a critical
component of sustainable treatment
programs.
By 2008, more than 80% of donor-funded
purchases of ARVs for use in developing
countries were generics from India,
including 91% of those formulated for
children.7 In 2010 alone, PEPFAR reported
saving $380 million through the purchase of
generic versus originator ARVs.8
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TPP Issue Brief â&#x20AC;&#x201C; August 2012

The Role Intellectual Property Plays in Blocking Access to Affordable Medicines
The TRIPS Agreement
Prior to the creation of the World Trade Organization (WTO) in 1995, countries retained the right to
shape their intellectual property laws to meet national needs; as a result, many countries did not grant
patents on pharmaceuticals, or made use of flexibilities in IP law to balance commercial and public
health interests, ensuring that “the interests of profit” did not impede “delivery of health care.” 9
When the WTO was formed, the world’s most comprehensive multilateral agreement on IP to date
came into force:10 the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS
Agreement). The TRIPS Agreement imposes minimum standards for protecting and enforcing IP rights,
including a 20-year minimum for patent protections,11 and determines many of the rules that restrict or
enable access to medicines. Developing countries have since struggled to strike a balance between
protecting public health and implementing TRIPS-compliant intellectual property laws.
Patents and IP Hinder Affordability, Accessibility of Medicines
Patents keep the price of medicines high and are a barrier to accessing affordable drugs. In developing
countries, where people often pay for drugs out of their own pockets and very seldom have health
insurance, the high price of medicines becomes a
question of life and death.
When patent barriers are removed, competition
between manufacturers enables production of
more affordable generic versions of medicines.
The impact can be tremendous: competition
helped to reduce the price of first-line HIV/AIDS
drugs by 99 percent over the last decade.
Doha Declaration Affirms TRIPS Flexibilities to Protect Public Health
When the damaging impact of the TRIPS Agreement on public health started to become evident, WTO
member states, including the U.S., signed the 2001 Doha Declaration on TRIPS and Public Health,12
reaffirming the primacy of public health over trade and confirming that the TRIPS Agreement can and
should be implemented in a manner supportive of WTO members’ right to promote access to medicines
for all. The flexibilities allowed under TRIPS are recognized as important public policy and legal tools in
the efforts to protect public health, and even wealthy nations like the U.S. have utilized these provisions.
“TRIPS-Plus” Provisions Roll Back Public Health Safeguards
However, over the last decade, many developing countries have come under pressure in trade
negotiations to implement tougher IP rules, known as “TRIPS-plus” provisions, which expand patent
monopolies, create new monopolies and preclude the use of flexibilities to protect public health.
The U.S. and the E.U. both have large pharmaceutical industries lobbying for stricter IP regulations, and
these interests tip the balance away from public health protections. Furthermore, these provisions
actually work to counter the efforts of global health programs, including those supported by the U.S.
government and other TPP negotiating parties, which rely heavily on decreasing medicine prices brought
about through generic competition.

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MSF Access Campaign
TPP Issue Brief – August 2012

Next Generation HIV Drug Pricing Remains Prohibitive
Demand for second-line
HIV treatments is growing
fast: it is estimated that
almost half a million
people will need these
medicines
this
year.
Today,
the
most
affordable
second-line
regimen is still twice as
expensive
as
the
recommended first-line
regimen, and the price of
a third-line regimen is
more than 14 times higher
than the recommended
first-line regimen.
As most second- and
third-line ARV drugs are Source: MSF Untangling the Web of antiretroviral Price Reductions, 15th Edition, July 2012
still broadly protected by
patents, further price reductions will require stronger competition via greater use of the flexibilities reiterated
under the DOHA Declaration. The TRIPS-plus provisions being pursued by the U.S. government in the TPP will
make it more difficult to pursue these needed strategies in the future.

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MSF Access Campaign
TPP Issue Brief â&#x20AC;&#x201C; August 2012

Lack of Medical Innovation to Meet Developing Country Needs
Stringent IP protection and enforcement norms are often justified based on the premise that they are
uniquely necessary as a means of encouraging innovation and the development of new medicines.
However, as the WHO Commission on Intellectual Property, Innovation and Public Health (CIPIH)
concluded in 2006,13 “for diseases affecting millions of poor people in developing countries, patents are
not a relevant factor or effective in stimulating R&D and bringing new products to the market.”
In fact, stringent IP norms have had little to no effect in spurring innovations needed for developing
countries, and in reality have detrimental effects on innovation and access.14 In contrast, the absence of
IP regulations has yielded positive results in innovation to meet developing country needs, for example
in allowing the development of better adapted and more appropriate medical technologies, such as
fixed-dose combinations and pediatric formulations of HIV medicines.
In April 2012, a landmark report by the Consultative Expert Working Group on Research and
Development: Financing and Coordination (CEWG), concluded that a different innovation system is
needed, including incentives mechanisms that de-link or separate the costs of research and
development from the price of products. The CEWG final recommendation is for a binding global
Research and Development Convention to secure appropriate funding, priority-setting and coordination
to promote R&D needed to address the diseases that affect developing countries, and to break the link
between the cost of R&D and the price of products.15
Today’s R&D Model Neglects Needs of the Poorest Patients
MSF is a humanitarian medical organization that needs and welcomes biomedical innovation to better treat our
patients. MSF recognizes the importance of innovation and the need to finance medical research and
development.
However, the reality is that intellectual property protection in the medical field keeps prices high and limits access
to treatment, and furthermore does not stimulate innovation for many of the diseases affecting people in
developing countries, where patients have limited purchasing power.
By seeking higher intellectual property norms in developing countries, the U.S. government is perpetuating a
failed business model that links innovation costs to high prices, and does not adequately address the
innovation needs of developing countries.

The U.S. Position Turns its Back on Previous U.S. Global Health Commitments
The leaked drafts of the U.S. negotiating positions for the TPP show that the U.S. is demanding
aggressive intellectual property provisions that, if accepted, would trample public health safeguards
enshrined in international law, in favor of offering enhanced patent and data protections to
pharmaceutical companies that make it harder for TPP nations to gain access to more affordable generic
drugs.
With these demands, the U.S. is turning its back on previous U.S. global health commitments,
including:


The 2001 WTO Doha Declaration reaffirming the primacy of public health over trade and confirming
that the TRIPS Agreement, to which the U.S. is a party, can and should be implemented in a manner
supportive access to medicines



The 2008 World Health Assembly Resolution 61.21, the Global Strategy and Plan of Action on Public
Health, Innovation and Intellectual Property, to which the U.S. agreed, which states that countries

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MSF Access Campaign
TPP Issue Brief – August 2012

are required to “take into account, where appropriate, the impact on public health when
considering adopting or implementing more extensive intellectual property protection than required
by TRIPS”


The May 10, 2007 New Trade Policy16 (May 10 Agreement), in which Congress and the Bush
administration reached a bipartisan agreement to include important public health safeguards in
trade agreements with developing countries.17



The 2011 UN Political Declaration on HIV/AIDS, which recognizes the role that TRIPS flexibilities can
play in increasing access to treatment, and calls on UN members to “ensure that intellectual
property rights provisions in trade agreements do not undermine these existing flexibilities.”18

The May 10 Agreement represented “a fundamental
shift in U.S. trade policy,”19 scaling back some of the
harshest U.S. IP demands for developing countries in
order to strike a better balance between protection of
IP and public health needs.
However, the U.S. pharmaceutical industry has
aggressively lobbied against the May 10 Agreement
being applied to the TPP negotiations. Despite concerns
from several members of Congress,20 the USTR is
shifting U.S. policy away from the May 10 Agreement
and toward greater protection of IP rights for brandname pharmaceutical companies in the developing
world.
See Appendix A for a comparison of specific provisions
between the May 10 Agreement and what the U.S. is
demanding in the TPP.

The U.S.’s TPP Position Undermines Its
Own Global Health Commitments
On the one hand, the U.S. has declared ending
the AIDS epidemic a policy goal and affirmed
its support for initiatives such as PEPFAR and
the Global Fund.
On the other hand, the Administration is
pursuing trade policies that will restrict access
to affordable life-saving drugs.
Generic
medicines
significantly
lower
treatment costs and enable more lives to be
saved. Without continued access to new and
forthcoming generic drugs, the anti-AIDS goals
that the U.S. administration is championing
will be unattainable.

USTR’s TPP “Access to Medicines” Initiative is a Misnomer
-- Proposal Actually Restricts Generic Competition –
In September 2011, the USTR proposed its “Trade Enhancing Access to Medicines” (TEAM) initiative for
inclusion in the TPP, professedly aimed at “promoting access to medicines in TPP partner markets” via a
1
“TPP access window” designed to “expedite access to innovative and generic medicines.”
In reality, the TEAM initiative falls far short of increasing access to medicines and will instead likely hinder
generic competition. TEAM relies on weak voluntary measures to ostensibly speed the introduction of
monopoly-protected pharmaceuticals in developing countries. For example, TEAM offers pharmaceutical
firms an incentive of extended monopoly protection in developing countries where they register their intent
to market their product. Theses extensions on drug monopolies would be granted using some of the TRIPSplus provisions further explained below: patent term extensions, patent linkage and data exclusivity.
In other words, the TEAM initiative allows monopoly-protected manufacturers to ensure that generics
remain blocked from developing countries for an extended period of time using TRIPS-plus provisions. As
several key members of the U.S. Congress have noted, the “access window” would result in nothing other
2
than “further delays in marketing of generic medicines.”
(1) http://www.ustr.gov/webfm_send/3059, (2) http://infojustice.org/wp-content/uploads/2011/09/Four-DemocratReps-10192011.pdf

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MSF Access Campaign
TPP Issue Brief – August 2012

Specific U.S. Demands Threatening Access to Medicines
1) Broadening the scope of patentability: the U.S. wants to make it easier to patent minor
modifications of old medicines, regardless of whether they offer any therapeutic benefits
for patients
Existing Flexibility: The TRIPS agreement includes important flexibilities for governments to decide
what type of pharmaceutical products deserve to be protected by patents in a given country. Essential
requirements such as ‘novelty,’ ‘inventive step,’ and ‘industrial applicability’ can be defined by
lawmakers in different countries so they
are appropriate within the context of
national circumstances (i.e., public health
needs).
The TRIPS agreement allows countries to
set their own patentability standards, and
therefore developing countries like India,
Philippines and Argentina have started
defining grounds for rejecting a patent, for
instance if the pharmaceutical substance
claimed is just a new form of a known
substance.
This flexibility is important because it
allows governments to prohibit so-called
“evergreening,"
which
enables
pharmaceutical companies to extend the
patent life and monopoly protection of old
drugs
simply
by
making
minor
modifications to existing formulations or
dosages, without necessarily increasing the
therapeutic efficacy for patients, or by
identifying a new therapeutic use for an
existing medicine.
What the U.S. Wants: The U.S. is seeking
to erode this flexibility by requesting that
TPP countries introduce new rules that
would severely limit the ability of each
country to define what is ‘patentable.’
For example, the USTR proposal for the TPP
requests the patenting of a “new form, use
or method of using” and “new
formulations” of an existing product – even
if there is no increase in efficacy – a
provision that enables the practice of
evergreening.21
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MSF Access Campaign
TPP Issue Brief – August 2012

In addition, the U.S. seeks to require that plants and animals be patentable, as well as diagnostic,
therapeutic, and surgical methods for the treatment of humans or animals.22 The TRIPS Agreement
explicitly allows governments to exclude these inventions from patent protection. This provision goes
beyond even what U.S. law allows, which exempts practicing surgeons from patent liability23 and may
preclude the patentability of some diagnostic methods.
Impact on Access to Medicines: Evergreening significantly affects access to medicines by allowing
pharmaceutical companies to extend patent monopolies, potentially keep prices high indefinitely, and
delay the arrival of more affordable generic medicines into the market.
The patentability of surgical methods without an exemption for practicing surgeons is especially relevant
for MSF because it can raise doctors’ liabilities if they are found to infringe a patent during the practice
of a medical operation. This is the first time that the U.S. has included requirements to patent surgical
methods in a trade agreement with developing countries.
Examples: How Expanding the Scope of Patentability Impacts Access to Medicines
Cancer patent application rejected
In 2006, the Indian patent office rejected Novartis' patent application for a life-saving anti-cancer drug imatinib
mesylate on the grounds that the application claims a ‘new form of a known substance’ (Novartis’ patent
application was related to a particular crystal form of the salt of imatinib mesylate). This opened up generic
competition, bringing down prices from over US $2,400 per patient per year (ppy) to US $200 ppy. Novartis
appealed the decision and the case is currently pending an Indian Supreme Court hearing. The U.S.’s proposed IP
provisions in the TPP would have forbidden India to reject the patent and allowed Novartis to continue
evergreening its old drug.
HIV drug more expensive due to evergreening
GSK's original patents for Abacavir (ABC), an anti-retroviral, expired in 2009 and 2010, but the company has been
able to extend its monopoly in many countries, including in developing countries, by filing for additional patents
covering new formulations of the same drug.
In Malaysia, where GSK has been granted numerous patents for ABC, including for the “salt form” and pediatric
variations of the drug, the public sector pays more than US $1,200 ppy for pediatric ABC, more than 8 times the
price of the generic version in other countries, which sells for as low as US $139 ppy.
Sources: http://msfaccess.org/content/update-intellectual-property-battles-continue-india-novartis-trial-further-delayed; MSF
Untangling the Web of Antiretroviral Price Reductions, 14th Edition, July 2011.

2) Restrictions on pre-grant patent oppositions: the U.S. wants to make it harder to
challenge invalid or frivolous patents.
Existing Flexibility: The TRIPS agreement imposes no restrictions on filing an opposition to the granting
of a patent – either before it has been granted (pre-grant opposition) or after (post-grant opposition).
What the U.S. Wants: The USTR’s proposed provisions would forbid pre-grant oppositions in TPP
countries, even those that already have the mechanism incorporated in their national laws.24 This would
mean that third parties will have to wait until the patent is granted to challenge a weak or invalid
patent. Forbidding pre-grant patent oppositions not only makes it more costly and cumbersome to
oppose a patent, but also deprives patent offices of the benefit of the expertise of third parties or even
competitors to the applicant, who may be able to identify inaccuracies in the application before a patent
is approved.
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MSF Access Campaign
TPP Issue Brief – August 2012

Impact on Access to Medicines: Pre-grant oppositions have successfully precluded granting of patents
on several life-saving drugs, thus expanding access by allowing lower cost generics to enter the market.
The use of this safeguard has resulted in rejection (or withdrawal) of key patent applications on
important HIV/AIDS medications, including tenofovir, darunavir, nevirapine syrup and
lopinavir/ritonavir, allowing generic companies in India to continue to manufacture, supply and export
these HIV medicines to other developing countries. Patent oppositions are an essential public health
safeguard that can accelerate the entry of generic competition, improve the patent system through
public oversight, and help reduce over-patenting.
Example: How Pre-Grant Oppositions Can Preempt Granting of Invalid Patents
After India introduced patent protection for pharmaceutical products in 2005, Boehringer Ingelheim (BI) applied
for a patent on the hemihydrate form pediatric suspension of Nevirapine (NVP), a widely-used HIV drug. Civil
society groups filed a pre-grant opposition, and in June, 2008, the patent application was rejected by the Indian
patent office, allowing for unrestricted competition on the pediatric formulation.
Tenofovir Disoproxil Fumarate (TDF) is a key component of the preferred WHO-recommended first-line HIV drug
regimen. The basic patent has now expired in most countries, but Gilead has applied for additional patents.
Thanks to generic production that started in India in 2005 and to the patent oppositions filed by civil society
groups in 2006 and 2007 to safeguard production, the price of TDF fell dramatically between 2005 and 2010. In a
major victory for access to medicines, in Brazil, civil society groups filed an opposition contesting Gilead’s patent
application in December 2006. In September 2008, the Brazilian patent office agreed and published the patent
rejection. However, in January 2010, Gilead launched a legal challenge against the decision. Gilead also requested
a divisional patent, which was opposed by civil society groups in a pre-grant opposition and which was rejected in
May 2011.
Source for both: MSF Untangling the Web of antiretroviral Price Reductions, 15th Edition, July 2012

3) Expanding data exclusivity: the U.S. is seeking to grant a backdoor route to monopoly
status.
Existing Flexibility: Data exclusivity is not currently required in international law. The TRIPS agreement
requires Member States to protect clinical data, but there is no obligation to grant any period of
monopoly or exclusivity in the use of these data.
When a second entrant or generic manufacturer applies to register and sell a generic version of a
previously-registered medicine, the manufacturer has to provide data showing that their product is
bioequivalent to the original registration.25 The drug regulatory agency already has the necessary
clinical data for safety and efficacy, submitted by the originator, and must only assess if the generic
version meets bioequivalence standards.
The introduction of data exclusivity prevents drug regulatory agencies from referring to existing clinical
data to approve registration of generic versions of a drug by “locking up” the clinical data for a period of
years, shutting down the entry of price-lowering generic competition for the duration. Data exclusivity
essentially creates a new system for granting monopolies in order to prevent generic competition.
Generic manufacturers are forced to wait for the “data monopoly” period to end, even if the drug is
unpatented, and even when a compulsory license is issued to override the patent. The only way a
generic manufacturer can get a drug registered without access to existing clinical data is to repeat the
clinical trials. However, duplicating clinical trials is not only extremely costly, but also unethical, since
safety and efficacy has technically already been established, rendering further clinical trials medically
unnecessary.
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TPP Issue Brief – August 2012

Many experts and UN agencies, including WHO, UNDP and UNAIDS, have recommended developing
countries do not incorporate data exclusivity in their national laws (see Appendix B).
What the U.S. Wants: The USTR is currently
proposing at least five years of data exclusivity
for new chemical entities and at least three years
of data exclusivity for drugs containing an
already approved active ingredient.26
Moreover, the placeholder text calling for data
exclusivity for ‘biologic’ medicines in the TPP is
especially alarming. Pharmaceutical firms are
lobbying for the data exclusivity period for
biologics to be set at a minimum of 12 years.27
Because biologics are structured differently than
traditional chemical medicines, second-entrant
“generic” biologics are called ‘biosimilars’ or
“follow-on biologics,” and require a different
regulatory approval process. This would be the
first time the U.S. has included a demand on
biologics in a trade agreement, and if
incorporated in the TPP, it would considerably
delay the market entry of biosimilars.
It is unclear if the U.S. will renege on the public
health safeguards specified in the May 10
Agreement, where exceptions were allowed in
order to ensure governments could still
effectively implement public health safeguards,
including compulsory licenses, caps and
concurrent periods of exclusivity (vs. effectively
longer ‘consecutive’ periods of exclusivity).
Impact on Access to Medicines: Data exclusivity
can delay the registration of generic or biosimilar
versions of a medicine for many years. Some of
the newest breakthrough medicines are biologics
sold at extremely high prices. The introduction
of data exclusivity for biologics will delay the
introduction of affordable versions of these
medications. The need for low-cost biosimilar
alternatives to highly expensive lifesaving drugs,
including pegylated interferon to treat Hepatitis
C and herceptin to treat breast cancer, is acute.

Examples: How Data Exclusivity Keeps Prices
High and Delays Generic Introduction
Data exclusivity, when implemented in national law,
provides a distinct monopoly from patent rights that
often results in high prices and a delay in market entry
of generics.
As a part of the U.S.-Jordan FTA, Jordan implemented
(1)
data exclusivity. A 2007 study by Oxfam found that
of 103 medicines registered and launched since 2001
that had no patent protection in Jordan, at least 79
percent had no competition from a generic equivalent
as a consequence of data exclusivity. The study also
found that prices of these medicines under data
exclusivity were up to 800% higher than in
neighboring Egypt.
(2)

A 2010 CPATH study
determined that once
Guatemala enacted data exclusivity, some medicine
prices rose as much as 846 percent – even though just
a handful of medicines were under patent protection.
Data exclusivity raises the price of medicines even
when no patent exists. For example, in the U.S., the
price of colchicine, a treatment used mainly for gout,
rose more than 5000% after data exclusivity was
(3)
enacted. Colchicine has been in use for thousands
of years, costs almost nothing to produce, and cannot
be patented. Therefore, generic formulations of the
tablet have been widely available since the 19th
century. However, a new monopoly on colchicine was
created in 2009 when the FDA accepted clinical data
from a one-week trial of the drug and granted data
exclusivity to URL Pharma. URL Pharma subsequently
sued to force other manufacturers off the market, and
raised prices from $0.09 to $4.85 per pill.
Sources: (1) OXFAM, All Costs, No Benefits: How TRIPS-plus
intellectual property rules in the U.S.-Jordan FTA affect access to
medicines, 2007; (2) Kesselheim, A., Solomon, D., Incentives for Drug
Development — Incentives for Drug Development — The Curious
Case of Colchicine, N Engl J Med 2010; 362:2045-2047; (3) Shaffer,
E., Brenner, J., A Trade Agreement’s Impact On Access To Generic
Drugs, Health Aff September/October 2009 vol. 28 no. 5 w957-w968

Some Members of U.S. Congress have expressed formal opposition to the inclusion of any data
exclusivity relating to biologics in the TPP.28 In fact, the U.S itself is considering reducing its current data
exclusivity provision for biologics from 12 to 7 years, in order to reduce the cost of medicines.29 In
addition, the Federal Trade Commission (FTC) has even recommended eliminating data exclusivity for
biologics in the U.S.30

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TPP Issue Brief – August 2012

4) Requesting patent term extensions: the U.S. is seeking to keep generic competitors out of
the market, for longer
Existing Flexibility: The TRIPS Agreement requires patents to last 20 years, but imposes no additional
provisions to extend monopoly rights further.
What the U.S. Wants: The U.S.’s proposed terms in the TPP would allow brand name pharmaceutical
companies to lengthen this period by requiring countries to grant patent extensions of at least 5 years to
compensate for administrative delays in the regulatory or patent approval process.31 Even though the
May 10 Agreement recognized the harmful impact of patent term extensions on access to medicines,
and made them voluntary/optional for countries negotiating trade agreements with the U.S., the U.S. is
demanding that patent term extensions in the TPP be mandatory.
Impact on Access to Medicines: The extra years added to the patent are extra years in which the patent
holder can maintain a monopoly position and continue to charge artificially high prices for the drug, free
from generic competition. Patent term extensions further delay the entry of generic medicines. Both the
patent office and the drug regulatory authority have crucial roles to play in examining thousands of
patent applications and making sure that registered medicines are safe and of good quality. Based on
the provision that the US is proposing, the time taken to process patent and regulatory applications in
developing countries could extend patent monopolies unduly.

5) Requesting patent linkage: the U.S. is seeking to turn drug regulatory authorities into
‘patent police’
Existing Flexibility: Patent linkage is not only absent from international law, but is not even permitted in
many developed countries. For example, most countries in Europe do not impose linkage between
patent status and drug registration.
A drug’s patent status and its registration status—its approval to market the drug in a particular
country—are separate, each handled by separate government agencies with specific areas of
competency. Patent offices assess whether a drug is innovative and novel enough to be patented, and
national drug regulatory authorities assess whether a drug is of a high quality—safe and effective
enough to be registered for use by the population they are responsible for.
Patent linkage is a TRIPS-plus provision that forces drug regulatory authorities to assess whether a
generic drug could potentially infringe existing patents before approving its registration, but drug
regulators are simply are not equipped to evaluate patent validity; furthermore, it is up to the patent
owner itself to identify and pursue potential patent infringements through the judiciary, a practice
which ensures that the validity of a patent can be publicly questioned and held up to scrutiny before it is
enforced.
What the U.S. Wants: The USTR has proposed that patent linkage be required of TPP countries,
imposing more restrictive conditions for the registration of generic medicines in low-income nations
than are found in Europe, and creating an important new and burdensome role for national regulatory
authorities.
With this demand, the USTR is reneging on the May 10 Agreement, which made patent linkage optional
for countries negotiating trade agreements with the U.S.
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Impact on Access to Medicines: Patent linkage provisions delay the market entry of generic
medications. By requiring drug regulatory authorities to take on the responsibility of policing patents,
this aggressive TRIPS-plus provision hinders generic drug registration while circumventing patent dispute
processes between the patent holder and the patent authorities.

6) Imposing new forms of IP enforcement: the U.S. wants to allow customs officials to seize
shipments of drugs on mere suspicion of IP infringement and to delay generic competition
through threats of increased damages
Existing Flexibility: The TRIPS agreement
allows for considerable flexibility in
designing national mechanisms of IP
enforcement and permits exclusion of
border measures on patented products.
If
pharmaceutical
products
are
considered to be infringing trademarks,
the TRIPS Agreement only requires
governments to ensure customs officials
can seize drugs if they are the product of
willful and commercial scale actions (e.g.
drugs that misrepresent their source and
may have been purposefully adulterated
and are dangerous for public health).
Also, governments can limit damages or
the availability of injunctions (which
might otherwise prohibit a generic
company from marketing a drug) in the
interest of public health.

Example: How New Forms of IP Enforcement Cause
Unnecessary Drug Supply Interruptions
During 2008 and 2009, at least 19 shipments of generic
medicines from India to other countries were impounded
while in transit in Europe on grounds that the shipments were
suspected of infringing trademark and patent rights in Europe.
However, the shipments were bound for countries where the
products would not infringe patent rights.
In one instance, German customs authorities wrongfully seized
a drug shipment of “Amoxicillin” on the suspicion that it
infringed the brand name “Amoxil” – the cargo was detained
for four weeks while further investigation took place,
eventually revealing that there was no trademark
infringement at all.
In another instance, the Dutch customs authorities seized a
shipment of the AIDS drug abacavir sulfate while it was en
route (via Europe) from India to a Clinton Foundation project
in Nigeria. The result was a disruption in the supply chain of
legal generic drugs.
Sources: WTO, European Union and a Member State – Seizure Of Generic
Drugs in Transit, May 19, 2010. Zarocostas, J., Brazil and India file complaint
against EU over seizure of generic drugs, BMJ 2010;340:c2672

What the U.S. Wants:
The U.S.’s
proposed terms would eliminate some of
these flexibilities. The U.S. is demanding that TPP countries implement and apply stronger enforcement
measures than required by international law.
The U.S. is requesting that TPP countries grant customs officials the ex-officio right to detain shipments
of medicines at the border, even for generic medicines in transit to developing countries, when they are
suspected of civil, non-counterfeiting trademark infringement.32 But customs officials are not equipped
to apply trademark law’s complex multi-factor tests. The U.S. proposal conflates pure commercial
trademark disputes and criminal offenses, such as production of counterfeit, falsified, or substandard
medicines.33 The result is a policy that could harm, rather than help, public health, by delaying legitimate
medicines en route to people who need them in developing countries.
The US also seeks to require mandatory injunctions for alleged IP violations. This runs counter to
provisions in TRIPS that allow for the possibility of judicially authorized licenses and royalty payments as
damages. Furthermore, the U.S. is requesting TPP countries to mandate that judicial authorities consider
valuing damages based on “the suggested retail price or other legitimate measure of value submitted by
the right holder” in cases of infringement of intellectual property rights,”34 a mechanism that strongly
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TPP Issue Brief – August 2012

favors the rights holder and increases damage amounts. Each country should have the flexibility to
individually determine the appropriate remedy and measure for damages for IP infringement.
Impact on Access to Medicines: Increased enforcement of IP laws has already been used to limit
legitimate trade in generic medicines between developing countries. Extending IP enforcement rules
beyond the enforcement measures required in the TRIPS agreement, and without safeguards against
abuse, widens opportunities to disrupt legitimate trade in generic medicines. Customs and border
officials often do not have the necessary expertise to make accurate assessments with regard to
intellectual property disputes, yet will be granted the power to seize medicines on a mere suspicion or
allegation of IP infringement. Unwarranted interception of legitimate in-transit pharmaceutical supplies
can undermine legitimate trade in generic medicines. Furthermore, MSF purchases and stores medicines
for use in our medical operations in different countries and such rules, if implemented, may affect our
operations. If TPP countries agree to the U.S.’s proposal for valuing damages, their judiciaries will have
their hands tied and will no longer be able to balance intellectual property rights with public health.

Enacting ACTA Provisions Through the Back Door Via TPP
Many have expressed concerns about the Anti-Counterfeiting Trade Agreement (ACTA) and the impact it could
have on access to generic medicines. Although several countries signed the agreement, so far no signatory has
ratified it, and in July 2012, the European Parliament voted by an impressive majority to reject it. In addition, the
Australian Parliament’s Joint Standing Committee on Treaties has cautioned against the ratification of ACTA.
ACTA was purported to protect against counterfeiting across a number of industries, including for medicines,
where it was promoted as a way of blocking potentially harmful ‘counterfeit’ medicines. But the provisions in
ACTA actually threatened fair, legitimate trade in generics, while failing to address the need to strengthen
regulatory authorities in combating substandard medicines.
MSF strongly supports efforts to ensure that medicines meet accepted international standards of quality, safety,
and efficacy; however ACTA’s excessive enforcement provisions left too much room for error and did not
address the underlying public health problem of poor quality, substandard medicines.
The numerous threats that ACTA would pose to access to medicines include:






ACTA would impede access to generic medicines while extending IP protection and enforcement measures
in ways that curb access to affordable treatment, to the detriment of patients and treatment providers alike
ACTA would allow border detention of in-transit medicines destined for developing countries, which leaves
legitimate trade in generic medicines open to unwarranted disruption
The stringent provisions in ACTA would also target third parties – including treatment providers like MSF –
by exposing them to the risk of punitive action in infringement allegations
ACTA would be deterrent to generic medicine production and trade by shifting the risk of excessive
punishments entirely on to generic manufacturers, and granting few protections against abuse
ACTA is a cynical exploitation of concerns about unsafe medicines, and is not a legitimate response to the
public health problem of substandard medicines

Yet similarly harmful provisions are still being pursued in the TPP. If they are accepted, the effect on access to
medicines will be chilling.
Source: http://www.msfaccess.org/content/acta-and-its-impact-access-medicines

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This briefing note has primarily addressed the U.S. government demands on patents and intellectual
property, but the TPP contains other chapters that, if accepted, would also negatively affect access to
medicines in developing countries. The following two provisions, from the pharmaceutical pricing and
investment chapters, could have a detrimental effect on access to medicines.

7) Pharmaceutical pricing chapter: the U.S. is seeking to assist pharmaceutical companies in
locking in high prices
According to the leaked text, the USTR’s proposed terms would force government pharmaceutical
reimbursement or price control programs that exist in some countries to reflect the “market value” of
drugs, thereby increasing the purchase price and restricting the capacity of governments to negotiate
discounts or price reductions.
The U.S. proposal for the TPP mandates that governments buy medicines at much higher fixed prices,
allows pharmaceutical companies to be part of the decision making process, and even allows
pharmaceutical firms to challenge government decisions. The TPP agreement would be the first trade
agreement where the U.S. is known to be proposing a standard that would restrict the operation of nondiscriminatory domestic pharmaceutical price policies in developing countries. And the U.S. is proposing
these measures in an agreement it describes as having “global” and “gold standard” ambitions.

8) Investment chapter: the U.S. wants to allow pharmaceutical companies to sue
governments and limit their ability to effectively set medicines prices
The leaked TPP investment chapter
contains provisions that would give private
corporations the right to sue governments
if the regulatory environment negatively
affects their “investments,” including
expected profits.
The definition given to ‘investment’ in the
TPP encompasses intangible investments,
including intellectual property.35 Granting
companies these rights could therefore
undermine TPP governments’ ability to
issue regulations to protect public health
and promote access to medicines, and
expose them to lawsuits from corporations
that claim their IP rights are being infringed
upon by government action.

Example: Challenging Public Interest Regulations
Through Investor-to-State Arbitration
Investor-state tribunals have proven to be extremely
problematic, undermining legislative, administrative, and
judicial decisions to protect other public health issues.
The tobacco company Philip Morris is currently capitalizing
on investment rules in trade deals to sue Uruguay and
Australia for introducing packaging laws banning branding
on cigarette packaging as part of their public health
campaigns against smoking. Philip Morris claims that by
ensuring that public health warnings are included on
cigarette packaging and removing branding from cigarette
packaging, governments are infringing on the tobacco
company’s trademark and investment rights.
Sources: http://www.bbc.co.uk/news/world-asia-15815311,
http://en.mercopress.com/2012/03/19/philip-morris-sues-uruguaycigarette-labeling-claiming-violation-of-investment-treaty.

This could happen if, for example, a government decided to regulate drug prices. A company could then
claim that the government’s action negatively impacts their ‘investment’ in the country.
To resolve disputes, the TPP proposal creates extra-judicial international investor-state tribunals that
bypass national judicial systems and even WTO-based dispute settlement mechanisms, can override
national laws and issue penalties for failure to comply with its rulings, and that make decisions via
closed-door processes that are usually unappealable.
16

TRIPS flexibilities for public health
Countries have the right to define
patentability criteria; for example, to
only grant patents for truly innovative
products and to exclude certain products
from patentability
Countries have the right to create patent
challenge mechanisms. The TRIPS
agreement contains no limits on the
possibility of pre- or post- grant patent
challenges

Countries have the right to define data
protection provisions that do not grant
market exclusivity or monopolies; data
exclusivity is not included in the TRIPS
agreement

Mandated, but for a maximum
of five years; exceptions
allowed for public health

Patent term
extensions

Patent linkage

Compulsory
licenses

17

TRIPS agreement only requires 20-year
patent terms; term extensions are not in
the TRIPS agreement
Countries have the right to grant
regulatory approval of generic medicines
independent from patent status; patent
linkage is not in the TRIPS agreement
Countries can issue compulsory licenses
and can authorize the use of a patented
product without the authorization of the
patent holder for a variety of reasons,
including public health

U.S. “TRIPS-plus” proposals for TPP
USTR leaked position expands scope of patentability to include:
- new forms & uses, methods of using and new formulations even if no
increase in efficacy (“evergreening” of old drugs)
- patenting of plants & animals, and diagnostic, therapeutic, & surgical
methods

USTR position requires countries to extend 20-year patent terms to
compensate for delays in regulatory or patent approval processes

The implementation of patentlinkage is optional

USTR position requires countries to mandate that regulatory authorities
check for patent infringement before granting regulatory approval of a drug

Recognizing that data
exclusivity can eliminate
effectiveness of compulsory
licenses by delaying entry of
generics, a public health
exception to data exclusivity is
allowed

No mention in leaked USTR position, but several provisions could potentially
make compulsory licenses ineffective

MSF Access Campaign
TPP Issue Brief – August 2012

APPENDIX B: What Others Are Saying About the TPP
Global Commission on HIV and the Law: Risks, Rights and Health, July 2012.36
“Free trade agreements (FTAs) and economic partnership agreements (EPAs) containing TRIPS-plus
standards also threaten access to medicines. A case in point is the United States–promoted Transpacific
Partnership Agreement (TPPA). Among other terms friendly to the United States pharmaceutical
industry, the proposed patenting standards would allow patenting of new forms, new uses and new
formulation of existing medicine; extend patent terms; and restrict the use of price control mechanisms.
In another example, the proposed EU-India FTA would shrink the latitude of countries to adopt policies
promoting the production and distribution of generic medicines. The United States trade stance, which
threatens access to affordable medicines for millions of the world’s poorest people, is egregious given
President Barack Obama’s professed commitments to increased economic equality and access to health
care in the United States. “
UNDP, UNAIDS Issue Brief, The Potential Impact of Free Trade Agreements on Public Health, 2012.37
"Assertions are often made about the advantages of TRIPS-plus protection but there has been little
evidence of the beneficial effects of TRIPS-plus measures either in the form of increased foreign
investment or increased innovation."
“To retain the benefits of TRIPS Agreement flexibilities, countries, at minimum should avoid entering into
FTAs that contain TRIPS-plus obligations that can impact on pharmaceuticals’ price or availability.”
UNAIDS, UNDP, WHO Joint Policy Brief, Using TRIPS flexibilities to improve access to HIV treatment,
2011.38
The document reiterates the WHO Global Strategy and Plan of Action recommendation that Member
States “take into account… the impact on public health when considering adoption or implementing
more extensive intellectual property protection than is required by the Agreement on Trade-Related
Aspects of Intellectual Property Rights.”
The document cites a number of TRIPS-plus provisions “that may have an impact on public health or
may hamper the use of TRIPS flexibilities, including: test data protection [data exclusivity]; requiring
countries to loosen the criteria for patentability; providing for the possibility of extensions of terms for
individual patents … to compensate for delays in … approval processes; and limiting the grounds under
which a patent may be revoked.”
The document recommends that “high-income governments should ensure that free trade agreements
with middle- or low-income countries comply with the principles of the Doha Declaration”
Global Fund to Fight AIDS, Tuberculosis and Malaria: Report of the Market Dynamics and
Commodities Ad Hoc Committee,39 May 11-12, 2011.
The report expresses concern about the potential impact of the proposed EU-India FTA on prices of, and
access to, HIV treatment. The report emphasized that countries should use TRIPS flexibilities to achieve
the lowest possible prices for products of assured quality
UNAIDS Press Release, December 9, 2010: Trade agreements should not hinder efforts towards
universal access to HIV prevention, treatment, care and support.40
“In this current economic climate, resources for AIDS have already flattened and need for treatment
continues to outstrip supply. Trade agreements that place additional burdens on the manufacture,
import or export lifesaving medicines—so-called ‘TRIPS plus’ measures such as ‘data exclusivity’—and
incorrect interpretations of the term ‘counterfeit’ should be avoided.”

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UN Special Rapporteur, Annual Report to the Human Rights Council, A/HRC/11/12, March 2009.41
“These agreements are usually negotiated with little transparency or participation from the public, and
often establish TRIPS-plus provisions. These provisions undermine the safeguards and flexibilities that
developing countries sought to preserve under TRIPS. Studies indicate that TRIPS-plus standards increase
medicine prices as they delay or restrict the introduction of generic competition.”
Some of the recommendations included:
“100. Developing countries and LDCs should establish high patentability standards and provide for
exclusions from patentability, such as new forms and new or second uses, and combinations, in order to
address evergreening and facilitate generic entry of medicines.
105. Developing countries and LDCs should establish liberal pre-grant, post-grant opposition and
revocation procedures, which can be taken advantage of by all concerned stakeholders, including
patients’ groups.
108. Developing countries and LDCs should not introduce TRIPS-plus standards in their national laws.
Developed countries should not encourage developing countries and LDCs to enter into TRIPS-plus FTAs
and should be mindful of actions which may infringe upon the right to health.”
WHO, Briefing Note: Access to Medicines, March 2006.42
“From the perspective of public health and access to medicines, it is preferable not to grant data
exclusivity. Moreover, there is no requirement under international law that countries grant data
exclusivity; countries only have to provide for data protection” …. “TRIPS plus’ requirements have at
times been incorporated in bilateral or regional free trade negotiations, in bilateral investment
agreements and in other international agreements and treaties. From the perspective of access to
medicines, this is a worrying trend; countries should therefore be vigilant and should not ‘trade away’
their people’s right to have access to medicines.”

U.S. Congressional Support for Ensuring Access to Medicines is Protected in the TPP:
Senator Bernie Sanders (I-VT): Letter to Ambassador Ron Kirk, December 1, 2011.43
Senator Sanders objects to USTR's position with regard to access to medicines in the TPP and the
apparent retreat from the May 10th Agreement. Senator Sanders also objects to the secrecy of the
negotiations and calls for the public release of the TPP negotiating texts.
“I join other member of Congress in calling for improvement of the USTR's position in this negotiation,
including the incorporation of the May 10 Agreement provisions.”
Senator notes that the USTR’s Trade Enhancing Access to Medicines (TEAM) approach is a
“disingenuously named initiative [that] does not balance trade with access to medicines. Rather, it would
erect even higher intellectual property barriers to affordable generic medicines for millions.”
10 Congressional Representatives: Letter to Ambassador Ron Kirk, August 2, 2011.44
Members of Congress expressed concerns that the public health interests of developing countries are
not being effectively addressed.
“We are concerned… that the balance is once again shifting away from… access to affordable medicines
and towards the greater protection of intellectual property rights for brand-name pharmaceutical
companies in the developing world, a move that would jeopardize treatment goals and millions of lives.”
“TRIPS-plus provisions in FTAs have been demonstrated to dramatically increase the cost of medicines in
developing countries, pricing medicines out of reach of the poor and straining public health budgets.”

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Representative Henry Waxman (D-CA), Representative Sander Levin (D-MI), Representative John
Conyers Jr. (D-MI), Representative Jim McDermott (D-WA): Letter to Ambassador Ron Kirk, October
19, 2011.45
Members of Congress ask the USTR to ensure that the TPP upholds U.S. commitments to safeguard
access to medicines in the development world.
“We are concerned that some of the goals and approaches described as part of the new strategic
initiative Trade Enhancing Access to Medicines (TEAM) could limit, rather than expand, access to
medicines in poor countries… The best way to preserve our developing country trade partners’ access to
medicines is to incorporate in the TPP the Bipartisan Agreement on Trade Policy of May 10, 2007…
“There would be significant concern if action through TPP could delay access to generic medicines which
may result in higher costs to the U.S. government to reach PEPFAR treatment goals or could result in
removing patients from treatment.”
Representative John Lewis (D-GA), Representative Pete Stark (D-CA), Representative Charles Rangel
(D-NY), Representative Earl Blumenauer (D-OR), Representative Llyod Doggett (D-TX): Letter to
Ambassador Ron Kirk, September 8, 2011.46
Members advocated for improved public health standards in TPP negotiations, especially relating to
global health and access to medicines.
“The standards established by this agreement should reflect our shared goals to improve global health
and access to medicines. The terms agreed to by Congress and President Bush on May 10, 2007 should
be considered a non-negotiable starting point for the TPP negotiations.”
“…we have long urged an improved and transparent interagency process and structured consultations
with public health interests regarding the potential impact of IP and pharmaceutical provisions on U.S.
and global public health efforts.”

U.S. Congressional Support for Ensuring More Transparency in the TPP:
132 Congressional Members: Letter to Ambassador Ron Kirk, June 27, 2012.47
Congressmen asked for more transparency in the TPP negotiations. Chief among their concerns was the
lack of consultation with Congress.
“According to USTR statements, the TPP membership could ultimately include half of the nations in the
world…We are troubled that important policy decisions are being made without full input from
Congress… Under the trade advisory system, representatives from over 600 business interests have such
access to both USTR negotiators and the negotiating text. However, American small business, civil
society, and other interests who have a direct and long-term interest in the outcome of these
negotiations have little meaningful input. In the past, most important U.S. trade agreement texts have
not been made available until after they were signed and changes were all but impossible. If Congress
and the public are not informed of the exact terms of the agreement until the conclusion of the process,
then any opportunity for meaningful input is lost.”
Senator Sherrod Brown (D-OH), Senator Ronald Wyden (D-OR), Senator Jeff Merkley (D-OR), Senator
Bob Menendez (D-NJ): Letter to Ambassador Ron Kirk,48 June 25, 20120, and Press Release,49 June 27,
2012.
Senators ask for greater congressional access to negotiations. From the press release:
“It’s troubling that corporate CEOs often have better access to information about trade negotiations
than the American people’s elected representatives—or the American people themselves,” Brown said.
“We must learn from the lessons of prior trade deals, and increase transparency when it comes to the

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ongoing negotiations regarding the Trans-Pacific Partnership—an agreement that may become a
template for all future trade agreements.”
From a news article50 quoting Senator Wyden: "The majority of Congress is being kept in the dark as to
the substance of the TPP negotiations, while representatives of U.S. corporations -- like Halliburton,
Chevron, PhRMA, Comcast and the Motion Picture Association of America -- are being consulted and
made privy to details of the agreement," said Wyden.
Representative Darrell Issa (R-CA): Letter to U.S. Trade Representative Ron Kirk, June 26, 2012.51
Senator Issa requested permission to observe the TPP talks that took place in California in July, 2012,
with the hope that observing the negotiating process would alleviate some concerns about the process
through which the agreement is being negotiated. His request was ultimately denied.52
Senator Ronald Wyden (D-OR): Legislation on trade agreement transparency, May 23, 2011.53
Wyden, chair of the Senate Finance Subcommittee on International Trade, introduced new legislation
that would require the White House to share trade documents with all members of Congress and their
qualified staff.
Representative Darrell Issa (R-CA): On May 15, 2012, House Oversight Committee Chairman Darrell Issa
called for more transparency in the negotiation process and leaked one of the draft intellectual property
chapter from the Trans-Pacific deal to the public on his website.54
Senator Al Franken (D-MN): Letter to Ambassador Ron Kirk, May 8, 2012.55
Franken urges transparency on the TPP.
“As your office has stated, it may ultimately be the single largest trade agreement by volume in U.S.
history. That makes it all the more important that the agreement be crafted in the most transparent and
participatory manner possible… I therefore request that, to the greatest extent possible, you make the
substance of the proposals you have tabled public and continue to do so at the conclusion of each
negotiating round.”